NCT03442608

Brief Summary

This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage. The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

January 16, 2018

Last Update Submit

February 23, 2018

Conditions

HypothermiaAneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Neurological function

    The neurological function will be evaluated at 6 months after hemorrhage by 2 specialized investigators who are unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school.

    6 months after hemorrhage

Secondary Outcomes (5)

  • Intracranial pressure

    Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed

  • Length of ICU stay

    6 months post hemorrhage

  • Length of hospital stay

    6 months post hemorrhage

  • Frequency of complications

    6 months post hemorrhage

  • Mortality rate

    6 months after hemorrhage

Study Arms (2)

mild hypothermia

EXPERIMENTAL

Device: Zoll 2000 and/or CureWrap 3500 cooling system,lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.

Procedure: Zoll 2000 and/or CureWrap 3500 cooling system

northermia

PLACEBO COMPARATOR

normal physical cooling methods,like ice bag, conditionally required.

Procedure: Zoll 2000 and/or CureWrap 3500 cooling system

Interventions

Zoll 2000 and/or CureWrap 3500 cooling systemPROCEDURE

Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.

mild hypothermianorthermia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 65 years within 72 hours after subarachnoid hemorrhage;
  • Neurosurgical clipping or coiling for aneurysm;
  • Hunt-Hess IV-V scale;
  • The intracranial pressure is more than 20 mmHg.

You may not qualify if:

  • GCS of 3 with bilateral fixed and dilated pupils;
  • No spontaneous breathing or cardiac arrest at the scene of hemorrhage;
  • No consent;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Seule MA, Muroi C, Mink S, Yonekawa Y, Keller E. Therapeutic hypothermia in patients with aneurysmal subarachnoid hemorrhage, refractory intracranial hypertension, or cerebral vasospasm. Neurosurgery. 2009 Jan;64(1):86-92; discussion 92-3. doi: 10.1227/01.NEU.0000336312.32773.A0.

    PMID: 19050656BACKGROUND

  • Qu X, Shang F, Zhao H, Qi M, Cheng W, Xu Y, Jiang L, Chen W, Wang N, Zhang H. Targeted temperature management at 33 degrees Celsius in patients with high-grade aneurysmal subarachnoid hemorrhage: a protocol for a multicenter randomized controlled study. Ann Transl Med. 2021 Apr;9(7):581. doi: 10.21037/atm-20-4719.

    PMID: 33987279DERIVED

MeSH Terms

Conditions

HypothermiaSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic Processes

Study Officials

  • Ning Wang, MD,PhD

    Xuanwu Hospital,Capital Medical University, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Qu, MD,PhD

CONTACT

86-10-83198633xinqu0213@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 22, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 26, 2018

Record last verified: 2018-02